Single, High Dose Vitamin A Replacement in Patients Undergoing Hematopoietic Stem Cell Transplantation and Its Role on MBI-LCBI Rates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Vitamin A Level
研究概览
简要总结
The primary objective of this study is to establish that single dose vitamin A supplementation is feasible and safe in pediatric and young adult bone marrow transplant recipients until day +30 (± 7 days) after hematopoietic stem cell transplantation.
详细描述
The investigators' preliminary data suggest that low levels of vitamin A directly impact risk of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI), likely via decreased gut permeability, and they hypothesize supplemental vitamin A at the time of HSCT can reduce the risk of MBI-LCBI and gastrointestinal graft versus host disease (GI GVHD). A 3x3 dose escalation/de-escalation study design will be used to determine the safety and dosing required to maintain vitamin A levels in the upper quartile of normal range for age at day +30 (± 7 days) with single dose vitamin A supplementation prior to hematopoietic stem cell transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient undergoing HSCT.
排除标准
- •Vitamin A hypersensitivity or allergy.
- •Age less than 1 year at time of transplant.
- •Baseline pre-HSCT vitamin A levels higher than the upper quartile of normal range for age.
- •Enteral feeding or medication intolerance.
- •Pregnancy.
研究组 & 干预措施
Vitamin A
Participants receive single dose vitamin A supplementation prior to HSCT. A 3x3 dose escalation/de-escalation design will be used for this study.
干预措施: Vitamin A (Dietary Supplement)
结局指标
主要结局
Vitamin A Level
时间窗: 30 days after HSCT
Vitamin A level will be measured 30 days after HSCT.
次要结局
- Incidence of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI)(100 days after HSCT)